Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Abraxane (Prior Taxane Therapy)

Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.

Abraxane (No Prior Taxane Therapy)

Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Treated Population

Reporting Groups

Description

Abraxane (Prior Taxane Therapy)

Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest

Abraxane (No Prior Taxane Therapy)

Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest

Total

Total of all reporting groups

Baseline Measures

Abraxane (Prior Taxane Therapy)

Abraxane (No Prior Taxane Therapy)

Total

Overall Participants Analyzed [Units: Participants]

47

76

123

Age [Units: Years]Mean (Standard Deviation)

55.3 (9.78)

58.3 (10.88)

57.2 (10.54)

Gender [Units: Participants]

Female

47

76

123

Male

0

0

0

Race/Ethnicity, Customized [Units: Participants]

Asian

0

5

5

Black, of African Heritage

2

3

5

Native Hawaiian or Other Pacific Islander

1

0

1

White, Non-Hispanic/Non Latino

41

60

101

White, Hispanic or Latino

0

5

5

Other-Unspecified

3

3

6

Menopausal Status [Units: Participants]

Premenopausal

12

12

24

Postmenopausal

35

64

99

Stage at Primary Diagnosis [1] [Units: Participants]

Stage I

4

12

16

Stage IIa

7

12

19

Stage IIb

14

13

27

Stage IIIa

11

8

19

Stage IIIb

6

4

10

Stage IIIc

5

5

10

Stage IV

0

19

19

Unknown

0

3

3

[1]

Invasive breast cancer stages:

Stage I-cancer cells are breaking through to or invading normal surrounding breast tissue.

Eastern Cooperative Oncology Group (ECOG) Performance Status is used to assess the progress of disease in a patient, how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.

Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers [ Time Frame: Every 8 weeks from study start until disease progression; Up to 61 months ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
Institution may publish the results of its findings if a multicenter publication is not forthcoming within 18 months after study completion. Institution shall provide Celgene with a copy of the papers prior to their submission; Celgene shall complete its review within 60 days after receipt. Upon Celgene's request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of patentable material.